Requirement: We are looking for an associate with at least 2-8 years of experience for Statistical programmer position and 8+ years for senior programmer position.

Incumbent must have strong understanding of SAS Base/Macros/GTL and experience of SDTM/ADAM/TLFs creation as per CDISC standards.

They should be able to manage communication with customers, track and ensure quality on-time deliverables, suggest and drive implementation of process improvements for enhanced quality and efficiency gains, institute robust processes to ensure consistent outcomes with quicker turn-around time.

Key asks: Ability to handle programming activities independently Core and solid ADa M and TFL experience, e Sub will be an added value Strong SAS experience, any added experience of R will be good Therapeutic area experience – vaccines, I&I, oncology, biomarkers and PROs Detailed JD: Topic Details SDTM/ADAM Model and IG Thorough understanding of SDTM/ADAM concepts and challenges.

Good hold on the TAUG’s and related guidelines.

Hands on experience in implementing SDTM/ADAM concepts across TA’s and various phases of clinical trains.

Good understanding on previous versions on SDTM/ADAM guidelines Study Reporting Suggest creative solution approach for various business requirements to solve complex SDTM/ADa M Mapping and Programming problems (e.g.

creates modular reusable code, develops standard code or utilities, and designs interconnected programs.

Review and author documents related to deliverables (User Guide, CDARS Mapping Specification, OCF, Test Plans, SAS Logs and Programs).

Good understanding of all study documents including Protocol, SAP, Mock Shells, LOT, Analysis plan etc.

Hands on experience of development and review of study specific tables, listings and figures for various phases of clinical trials and across TA’s.

SAS Programming Expertise in Base and Advance SAS programming.

Expertise in developing macros and developing generalized programs.

Development of the complex SAS macros that can be utilized across TAs in multiple studies; review of the developed SAS programs.

Expertise in SQL, SAS Macros, Functions, SAS GTL, SASand other advanced SAS components.

Mentor and supervise developer to build generic standard macros, generic listings or other ad-hoc requests in accordance with business requirements.

Controlled Terminology Good understanding of code list and value list concepts.

Expertise in managing NCI codelist and tracking its updates.

Exposure to CDASH, SDTM/ADa M and ADa M lineage concepts Other CDISC IGs Exposure to Medical Device, Associated Patients, Oncology and other specific guidelines around CDISC SDTM/ADa M.

Hands on exposure in managing few of these activities Developing Mapping Specs Hands on experience in developing mapping specs for SDTM/ADa M.

Desirable to have hands on experience in developing mapping specs for a TA or global level SDTM/ADa M mappings.

Senior Statistical Programmer is responsible for review of developed SDTM/ADa M mapping specifications SDTM/ADa M Dataset Programming Hands on experience in generating SDTM/ADa M datasets using SAS programming or other tool-based approach.

SDTM/ADa M Compliance & Define Hands on experience generating define.xml files, experience in performing SDTM/ADa M compliance checking using P21 or other compliance checks.

Validation Implement QA and QC validation in accordance with Departmental SOP’s for deliverables including: Formal study reports Data review Presentations Adhoc-requests Along with this the candidate must have good understanding of Exposure to software development or global macro development process Exposure in developing user specifications, developing global macros, unit testing Experience in handling development and maintenance projects Change Management and Version control process Clinical guidelines understanding like ICH-GCP, SDTM/ADAM IGs etc.

Client management, communication, project management and other soft skills Good team player